WASHINGTON, DC — More than 4.3 million tubes of fluoride toothpaste sold nationwide have been voluntarily recalled after the Food and Drug Administration identified manufacturing problems at the plant that produced them. Many of the affected products were marketed to children and came in flavors such as bubble gum, strawberry and watermelon.
The recall includes tubes sold under licensed character brands, along with several lesser-known labels. Expiration dates on the affected products run from November 2026 through June 2028, which means some may still be in bathrooms and medicine cabinets across the country.
No illnesses or injuries have been reported. Even so, the FDA is telling consumers to check whether their toothpaste matches the recall by reviewing the brand, lot number and expiration date.
Why the FDA says the toothpaste was recalled
The FDA said the recall was triggered by current good manufacturing practice deviations at the facility that made the toothpaste. Those standards are designed to make sure products are produced consistently and safely.
A deviation from those rules does not automatically mean a product is dangerous. It does mean the manufacturing process did not meet federal requirements, which is why the recall was issued and later classified by the agency.
Pritam International Private Limited, the India-based manufacturer, initiated the voluntary recall on Sept. 10. The FDA later classified it as a Class II recall on Oct. 19, a category used for products that could cause temporary or medically reversible health problems, with serious harm considered unlikely.
Which toothpaste brands and sizes are included
The recalled products were distributed by Ashtel Studios Inc. of Ontario, California. They include toothpaste sold under the Brush Buddies, Crayola, Hot Wheels and My Little Pony names, along with some other labels.
Flavors named in the recall include bubble gum, strawberry, watermelon, peppermint, sweet mint and cool mint. The products were sold in 3.5-ounce and 4-ounce tubes, as well as a two-pack of 3.5-ounce tubes.
Consumers are being told to compare their packaging with the FDA recall notice, since the affected tubes were distributed nationwide and some of the packaging may look familiar enough to be overlooked at a glance.
What families should do if they find a recalled tube
The FDA’s notice does not provide specific consumer instructions, and neither the manufacturer nor the distributor has publicly explained how returns or refunds will work. For now, the safest step is to stop using the toothpaste immediately and throw it away.
Before discarding it, consumers should check the brand, lot number and expiration date against the FDA’s recall listing. If the product matches, families should replace it with another fluoride toothpaste so brushing routines are not interrupted.
It may also help to keep a receipt or take a photo of the package before tossing it, in case a refund process is announced later. If anyone has concerns after using the product, the FDA says they should contact a dentist or doctor.
Why the recall matters even without reported injuries
The recall covers a very large number of tubes, and the affected products include child-focused brands that are often used daily. Because some expiration dates extend into 2028, toothpaste from the recall could remain in homes long after purchase.
Still, the FDA has not reported any illnesses or injuries tied to the recalled toothpaste. That is one reason the recall was classified as Class II rather than a more severe category.
Even so, the agency’s warning matters because toothpaste is a routine household product used directly in the mouth. Families with children may be especially motivated to double-check what is sitting on the bathroom shelf.
How consumers can replace the recalled toothpaste
Consumers who discover a recalled tube are being advised to switch to another fluoride toothpaste right away. The recall notice does not name a replacement product, but the broader point is to keep brushing with a non-recalled option.
Any product chosen should be checked carefully against the FDA notice if it is from the same brand family or was purchased around the same time. The recall covers both kid-themed and adult toothpaste, so buyers should not assume only children’s products are affected.
Families looking for a substitute should keep the focus on the recall status first. The key safety step is verifying the lot number and expiration date before continuing to use any similar tube already at home.
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